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Clinical Trials (PDQ®)

Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer (Cetuximab Closed as of 05/14/10)

Basic Trial Information
Trial Description
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overNCI, OtherRTOG-0839
CDR0000654690, NCI-2011-01970, NCT00979212

Trial Description


RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without panitumumab in treating patients with non-small cell lung cancer. (cetuximab closed as of 05/14/10)

PURPOSE: This randomized phase II trial is studying chemotherapy and radiation therapy to see how well they work when given with or without panitumumab in treating patients with stage IIIA non-small cell lung cancer. (cetuximab closed as of 05/14/10)

Further Study Information



  • Determine the mediastinal nodal clearance after completion of induction chemoradiotherapy with or without panitumumab in patients with stage IIIA non-small cell lung cancer. (cetuximab closed as of 05/14/10)


  • Assess overall survival of these patients.
  • Evaluate patterns of first failure in these patients.
  • Determine the acute and late adverse events associated with these regimens.
  • Assess surgical morbidities in patients with resectable disease at reassessment.
  • Determine the correlation between pre- and post-treatment biomarkers (including epidermal growth factor receptor (EGFR) and ras mutation status) and outcomes (mediastinal nodal clearance and overall survival).
  • Evaluate the prognostic value of plasma osteopontin and microRNA for overall survival.
  • Assess the ability of FDG-PET/CT scan re-staging to predict outcome.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive induction therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Patients also undergo intensity-modulated radiotherapy (IMRT) or 3-dimensional conformal radiotherapy (3D-CRT) once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning approximately 6-12 weeks later, patients receive consolidation therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 and 21.
  • Arm II: Patients receive induction therapy comprising panitumumab IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 8, 15, 22, 29, and 36. Patients also undergo IMRT or 3D-CRT once daily on days 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Beginning approximately 6-12 weeks later, patients receive consolidation therapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1 and 21. (cetuximab closed as of 05/14/10) In both arms, patients with resectable disease and no disease progression may proceed to surgery (thoracotomy, lobectomy, or pneumonectomy) approximately 4-6 weeks after completion of induction therapy. After surgery, patients proceed to consolidation therapy.

After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Eligibility Criteria


  • Histologically confirmed* non-small cell lung cancer (NSCLC), including any of the following histologies:
  • Adenocarcinoma
  • Adenosquamous
  • Large cell carcinoma
  • Squamous cell carcinoma
  • Non-lobar and non-diffuse bronchoalveolar cell carcinoma
  • NSCLC not otherwise specified NOTE: *Documentation of NSCLC may originate from the mediastinal node biopsy or aspiration
  • Stage IIIA (T1-T3) disease with a single primary lung parenchymal lesion AND positive ipsilateral mediastinal node or nodes (N2) with or without positive ipsilateral hilar nodes (N1)
  • N2 nodes must be separate from primary tumor by either CT scan or surgical exploration
  • Maximum nodal diameter of involved N2 nodes cannot exceed 3.0 cm
  • N2 status must be pathologically confirmed to be positive by one of the following methods*:
  • Mediastinoscopy
  • Mediastinotomy (Chamberlain procedure)
  • Transesophageal needle biopsy using endoscopic ultrasound (EUS-TBNA)
  • Endobronchial ultrasound biopsy using endoscopic ultrasound guidance (EBUS-TBNA)
  • Thoracotomy
  • Video-assisted thoracoscopy
  • Transbronchial needle biopsy by Wang technique (TBNA)
  • Fine-needle aspiration under CT guidance NOTE: *PET positivity in the ipsilateral mediastinal lymph nodes is not sufficient to establish N2 nodal status
  • Ipsilateral mediastinal nodes associated with right-sided tumor must be biopsied unless all of the following are true:
  • Tumor is left sided
  • Paralyzed left true vocal cord documented by bronchoscopy or indirect laryngoscopy
  • Nodes visible in the anterior/posterior (level 5) region on CT scan
  • Distinct primary tumor separate from nodes visible on CT scan
  • Histologic (biopsy) or cytologic (needle aspiration or sputum) proof of non-small cell histology from the primary tumor
  • If lymph nodes in the contralateral mediastinum and neck are visible on contrast CT scan of the chest and are > 1.0 cm in short axis or if contralateral involvement is suggested by PET scan, then the nodes must be confirmed to be negative
  • Measurable disease as determined by contrast-enhanced CT scan
  • Primary lung tumor distinct from mediastinal lymph nodes
  • Pleural effusion allowed provided one of the following criteria is met:
  • If pleural fluid is present either before or after pre-study mediastinoscopy or exploratory thoracotomy, a thoracentesis must be performed to document that the pleural effusion is cytologically negative
  • If pleural fluid is present on CT scan, but is deemed too small to tap safely under either CT scan or ultrasound guidance, a thoracoscopy should be done, if feasible, to document the absence of pleural metastases and to document that the pleural effusion is cytologically negative
  • No palpable lymph nodes in the supraclavicular areas or higher in the neck, unless proven to be benign by fine-needle aspiration or biopsy
  • No distant metastases


  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
  • Creatinine clearance ≥ 60 mL/min
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Serum albumin > 3.0 g/dL
  • Serum magnesium normal (supplementation allowed)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of treatment
  • Forced expiratory volume at one second (FEV1) ≥ 2.0 L OR predicted post-resection FEV1 ≥ 0.8 L
  • Diffusion capacity ≥ 50% predicted
  • No other invasive malignancy within the past 3 years, except nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
  • No severe, active co-morbidity, including any of the following:
  • Uncontrolled cardiac disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within the past 6 months, uncontrolled congestive heart failure, or cardiomyopathy [ejection fraction < 50%])
  • Acute bacterial or fungal infection requiring IV antibiotics
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or that would preclude study therapy within the past 4 weeks
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • AIDS or known HIV positivity
  • No unintentional weight loss ≥ 5% of body weight within the past 6 months
  • No prior severe infusion reaction to a monoclonal antibody
  • No pre-existing peripheral neuropathy ≥ grade 2


  • No prior systemic chemotherapy or biological therapy (including erlotinib hydrochloride or similar agents) for the study cancer
  • Prior chemotherapy for a different cancer allowed
  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
  • No prior therapy that specifically and directly targets the EGFR pathway

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

National Cancer Institute

Martin J. Edelman, MDPrincipal Investigator

Trial Sites

 Stanford Cancer Center
 Billy W Loo Ph: 650-498-7061
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
 Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
 Aaron W Pederson Ph: 912-350-8568
 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
 John A Pablo Ph: 800-622-6877
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Samir Narayan Ph: 734-712-4673
 Saint Joseph Hospital
 Nicholas S Galanopoulos Ph: 773-665-3109
 Central Dupage Cancer Center
 Nasiruddin Mohammed Ph: 630-352-5300
 Center for Cancer Care at Goshen General Hospital
 James A. Wheeler Ph: 574-535-2858
 University of Kentucky Chandler Medical Center
 Ronald McGarry Ph: 859-257-3379
 University of Louisville School of Medicine
 Neal E Dunlap Ph: 866-530-5516
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Mini J Elnaggar Ph: 888-562-4763
 Greenebaum Cancer Center at University of Maryland Medical Center
 Steven Feigenberg Ph: 800-888-8823
  Bel Air
 Upper Chesapeake Medical Center
 Steven Feigenberg Ph: 800-888-8823
 Boston University Cancer Research Center
 Gregory A Russo Ph: 617-638-8265
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Samir Narayan Ph: 734-712-4673
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Paul Sperduto Ph: 952-993-1517
 Fairview Southdale Hospital
 Paul Sperduto Ph: 952-993-1517
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Paul Sperduto Ph: 952-993-1517
 University of Mississippi Cancer Clinic
 Shankar P Giri Ph: 601-815-6700
 Methodist Estabrook Cancer Center
 Tien-Shew W Huang Ph: 402-354-5144
New York
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Simon K Cheng Ph: 212-305-8615
 SUNY Upstate Medical University Hospital
 Jeffrey A. Bogart Ph: 315-464-5476
 Summa Center for Cancer Care at Akron City Hospital
 Charles A Kunos Ph: 330-375-6101
 Barberton Citizens Hospital
 Charles A Kunos Ph: 330-375-6101
 Cleveland Clinic Taussig Cancer Center
 Gregory Videtic Ph: 866-223-8100
 Cleveland Clinic Foundation - Strongsville
 Gregory Videtic Ph: 866-223-8100
  Oklahoma City
 Stephenson Cancer Center at the University of Oklahoma
 Terence S. Herman Ph: 405-271-4272
  Bryn Mawr
 Bryn Mawr Hospital
 Albert S DeNittis Ph: 866-225-5654
 Geisinger Cancer Institute at Geisinger Health
 Thomas J Gergel Ph: 570-271-5251
 Adams Cancer Center
 Amit B. Shah Ph: 877-441-7957
 Cherry Tree Cancer Center
 Amit B. Shah Ph: 877-441-7957
 Cancer Center of Paoli Memorial Hospital
 Albert S DeNittis Ph: 866-225-5654
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Nathaniel R Evans Ph: 215-955-6084
 Allegheny Cancer Center at Allegheny General Hospital
 Athanasios Colonias Ph: 877-284-2000
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Albert Yuen Ph: 610-988-9323
 Lankenau Cancer Center at Lankenau Hospital
 Albert S DeNittis Ph: 866-225-5654
 WellSpan Health
 Amit B. Shah Ph: 877-441-7957
  Salt Lake City
 Huntsman Cancer Institute at University of Utah
 Shamus R Carr Ph: 801-581-4477
  Menomonee Falls
 Community Memorial Hospital Cancer Care Center
 Elizabeth M. Gore Ph: 414-805-4380
 Froedtert Hospital and Medical College of Wisconsin
 Elizabeth M. Gore Ph: 414-805-4380
 Veterans Affairs Medical Center - Milwaukee
 Elizabeth M. Gore Ph: 414-805-4380
  West Bend
 Alyce and Elmore Kraemer Cancer Care Center at St. Joseph's Hospital
 Elizabeth M. Gore Ph: 414-805-4380

Link to the current record.
NLM Identifer NCT00979212 processed this data on April 09, 2015

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to

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